Indications, Safety & Warnings

SX-One MicroKnife®

Intended Use:

The Sonex Health SX-One MicroKnife® is intended to transect the transverse carpal ligament for the treatment of carpal tunnel syndrome.

Indications for Use:

The SX-One MicroKnife is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.

Contraindications:

  • Presence of infection.
  • Distorted anatomy or other process within the carpal tunnel preventing safe and effective transection of the TCL.
  • Presence of condition requiring surgical intervention beyond transection of the TCL.
  • Additionally, in cases in which ultrasound guidance is used, inability to sonographically identify and protect relevant anatomic structures such as the nerves and vessels.

Possible Complications:

Operators should be familiar with the complications of carpal tunnel release using the SX-One MicroKnife®, including but not limited to:

  • Procedure related discomfort.
  • Infection.
  • Wound complications such as delayed healing, scarring or tenderness.
  • Pillar pain.
  • Bruising.
  • Injury to vessels, tendons or other soft tissues.
  • Injury to nerves such as the median nerve.
  • Development of a chronic pain process such as complex regional pain syndrome.
  • Recurrence.
  • Incomplete symptom resolution.
  • Additionally, in cases in which ultrasound guidance is used, inability to complete the ultrasound guided carpal tunnel release requiring discontinuation of the procedure.

Warnings:

  • Safe and successful transection of the TCL using the SX-One MicroKnife® is dependent upon appropriate training, knowledge carpal tunnel anatomy, and careful study and adherence to the surgical technique. Failure to properly follow the instructions, warnings and precautions may lead to serious surgical consequences or injury to the patient or operator.
  • Inflating the balloon beyond the maximum inflation volume may cause the balloon to rupture before reaching the maximum inflation pressure of 40 psi.
  • Inflating the balloon beyond the maximum inflation pressure may cause the balloon to rupture before reaching the maximum inflation volume.
  • Use of the SX-One MicroKnife® in conjunction with ultrasound guidance should only be performed by operators experienced in ultrasound guided procedures and who are properly trained and familiar with the correct operation of the SX-One MicroKnife® as outlined in this document.
  • The safety and effectiveness of the SX-One MicroKnife® to transect the TCL in cases of recurrent carpal tunnel syndrome has not been established.
  • The cutting blade of the SX-One MicroKnife® is extremely sharp. Exercise caution to prevent injury.
  • Device misuse, such as excessive prying, may damage the device, resulting in an inability to complete the procedure or potential injury.
  • If visualization of the device or relevant anatomical structures is impaired during the procedure, DO NOT continue until proper visualization is restored.
  • Following use, the device must be properly discarded in accordance with organizational policies and guidelines for sharps disposal.
  • Do NOT Re-sterilize. Single Use Only.

Precautions:

  • Operators using the SX-One MicroKnife® should be familiar with the surgical technique and the required instrumentation.
  • Operators using the SX-One MicroKnife® in conjunction with ultrasound guidance should be familiar with the use of ultrasound for interventional procedures.
  • Carpal tunnel release using the SX-One MicroKnife® represents a surgical procedure. Operators and staff should follow appropriate precautions and procedures.

The position of the patient’s hand should be controlled during the procedure. Unwanted hand movement may make the procedure more difficult or result in injury.

Product Users/Use Environment:

  • Customers: The device should be used by properly trained health care providers in hospital and clinic settings.
  • Users: The device should be used by a physician, surgeon, or other medical personnel qualified to perform a carpal tunnel release and/or ultrasound guided procedures (herein referred to as the operator).
  • Use Environments: Procedure room in a clinical facility such as an outpatient facility, physician’s office or a hospital.
  • Do not use if the sterile packaging has been altered or damaged.